HER2-positive early or locally advanced breast cancer
Conditions
Interventions
Observation group:None
Sponsors
Nanchang People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years and older, female; 2.Patients with treatment-na? ve primary invasive breast cancer (excluding occult, inflammatory and eczematoid breast cancer) diagnosed histopathologically as HER2 positive; 3.Primary tumor diameter> 2 cm by local standard assessment; tumor stage: early (T2-3, N0 -1, M0) or locally advanced (T2-3, N2 or N3, M0;T4, all N, M0), patients requiring neoadjuvant therapy and undergoing surgery, and neoadjuvant therapy using a regimen containing HP; 4.Have at least one evaluable target lesion per Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1; 5.ECOG performance status score 0 - 1; 6.For premenopausal or nonsurgically sterilized female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment; 7.Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up;
Exclusion criteria
Exclusion criteria: 1.Patients with known allergies to active ingredients or other ingredients of the study drug; 2.People who do not need neoadjuvant therapy; 3.Pregnant or lactating women, women of childbearing age who refuse to use effective contraception during the study; 4.Patients who require other anti-tumor therapy (except ovarian function inhibitors) and are not suitable for inclusion in the study according to the investigator's judgment; 5.Serious or uncontrolled infections that may affect study treatment or assessment of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc. 6.Mental illness, cognitive impairment, inability to understand study protocol and side effects, inability to complete study protocol and follow-up workers; 7. The researchers believe that the patient has any other conditions that make them unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rates;Different populations (HR status) pCR after neoadjuvant therapy;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactYali Cao
Nanchang People's Hospital
Outcome results
None listed